Menu
Recruiting NCT06065982

Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

— Observational End-stage Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: End-stage Kidney Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters

Overview

Peritoneal dialysis (PD) is the most frequent modality of home dialysis for patients with kidney failure. Most PD catheters are placed using a laparoscopic technique. This approach requires the availability of a qualified surgeon, time in the operating theater and general anaesthesia for the patient. Thus, the laparoscopic technique is less suitable for patients with severe heart failure or multimorbidity where general anaesthesia is not possible. PD catheters can also be inserted using a percutaneous strategy using a modified Seldinger technique. This strategy can be performed bedside under local anaesthesia, by the nephrologist, radiologist, a surgeon, physician assistant or qualified nurse. The availability of the percutaneous implantation strategy of a PD catheter in a nephrology center may accomodate more patients to receive a PD catheter insertion, including those who have a contraindication to general anaesthesia or need urgent PD. The PREDICT project aims to increase knowledge and competencies on percutaneous PD catheter insertions by training centers for this technique. By establisching a prospective registry, the outcomes of percutaneously inserted PD catheters, both in experienced and newly trained centers, will be assessed.

Detailed description

The population of the PREDICT study are adult patients requiring a peritoneal dialysis catheter insertion. Decision for percutaneous strategy of catheter insertion (versus surgical catheter insertion) is made by the treating physician.

The inclusion criteria for the prospective PREDICT registry are age \> 18 years and percutaneous PD catheter insertion between 1 March 2023 and 1 March 1 2026 in participating centers.

Patients can be included 4 weeks before until 12 weeks after PD catheter insertion. The exclusion criteria are the inability to give informed consent and a life expectancy of less than 3 months.

Demographic and clinical data will be collected for all included patients.

Interventions

  • Other Questionnaires
    Health-related quality of life will be measured using the 12-item Short Form (SF-12) and EQ5D-5L questionnaires. The SF-12 is summarized into two component scores, the Physical Component Score (PCS) and Mental Composite Score (MCS).

Primary outcome measures

  • Implementation of percutaneus PD catheter insertion technique in dialysis centers [Time frame: through study completion, 3 years]
  • Outcomes of percutaneous inserted PD catheters in participating centers [Time frame: Over 12 months after percutaneous insertion]
Secondary outcome measures (9)
  • The presence of functioning PD catheter [Time frame: Over 3 and 6 months after percutaneous PD catheter insertion]
  • Insertion-related complications [Time frame: Perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion, and PD-related infections within 30 days of insertion]
  • Mechanical complications [Time frame: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch]
  • The rate of PD utilization [Time frame: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch]
  • Health-related quality of life as assessed by the SF-12 questionnaire [Time frame: At baseline and at 12 months after percutaneous PD catheter insertion]
  • Self-assessed health-related quality of life using the EQ5D questionnaire. [Time frame: At baseline and at 12 months after percutaneous PD catheter insertion]
  • Health care professionals' perspective on the implementation process [Time frame: At baseline and yearly]
  • Evolution in HD/PD ratio in participating centers throughout the study period [Time frame: Through study completion, 3 years]
  • Costs of the procedure [Time frame: immediately after the intervention]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Percutaneous PD catheter insertion between March 1st 2023 and March 1st 2026 Patients can be included 4 weeks before until 12 weeks after PD catheter insertion

Exclusion criteria

  • Inability to provide informed consent
  • Life expectancy < 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Universitair Ziekenhuis Brussel — Brussels
Netherlands · 1 center
  • UMC Utrecht — Utrecht

Identifiers

NCT: NCT06065982 · UZB-NEF-2023-PREDICT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗